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临床试验/NCT03929432
NCT03929432进行中(未招募)不适用

Treatment Outcomes and Brain Mechanisms Associated With Non-Invasive Neuromodulation in Post-Stroke Aphasia

University of Arkansas1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年9月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
1
主要终点
Change in correct naming of nouns on Philadelphia Naming Test.

研究概览

简要总结

The purpose this study is to test the utility of pairing external neuromodulation with behavioral language treatment to boost therapy outcomes and to investigate the mechanisms associated with recovery. Because all PWA have word retrieval deficits, this project will test if greater language gains can be achieved by supplementing anomia intervention with excitatory brain stimulation to the left hemisphere and will evaluate associated functional brain changes to aid the optimization of neural reorganization to facilitate language processing.

详细描述

Aphasia is a language impairment that commonly occurs following brain damage (e.g., stroke). While language rehabilitation can yield improved language functioning, treatment outcomes vary greatly across individuals. In chronic aphasia, language gains occur through the brain's inherent ability to reorganize (i.e., neuroplasticity).

While Speech-language therapy (SLT) can target various language skills and modalities, the most pervasive deficit across all persons with aphasia (PWA) is difficulty with word finding. Thus, aphasia treatment often includes some form of intervention focused on improving naming abilities. As with language function in general, naming abilities in PWA seems to be associated with left hemisphere recruitment, particularly with the viable tissue at the rim of the lesion (perilesional areas). This project investigates an innovative approach to improving current therapy by examining the benefits of using excitatory transcranial direct current stimulation (tDCS) stimulation/neuromodulation during anomia treatment (i.e. word-finding treatment).

This study investigates an innovative approach to improving current therapy by examining the benefits of using excitatory tDCS stimulation/neuromodulation during anomia treatment. This project will provide novel mechanistic understanding of changes in functional brain connectivity in persons with post-stroke aphasia and how connectivity relates to treatment outcomes.

The aims of this study are as follows:

Aim 1. To investigate the benefits of using broad transcranial direct current stimulation (tDCS) to improve word retrieval in persons with aphasia (PWA). Aim 2. To study functional brain changes related to this treatment. Aim 3. To examine behavioral and neural re-organization correlates related to treatment outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Active tDCS versus sham tDCS will be masked to the participants

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of post-stroke aphasia
  • Single left hemisphere stroke etiology
  • At least 6 months post-stroke
  • Age range between 18 and 80 years old
  • Speak English as a native language
  • Adequate hearing and vision to complete the tasks

排除标准

  • Severe auditory comprehension deficits (determined by pretest) (i.e., global aphasia, Wernicke's aphasia, transcortical sensory aphasia)
  • Inability to provide informed consent
  • Co-occurring history of neurological disease/disorder/injury (e.g., traumatic brain injury, right hemisphere stroke, dementia)
  • Co-occurring history of a major mental illness (e.g., schizophrenia, drug addiction, bipolar)
  • Clinical conditions contraindicated for MRI or tDCS (e.g., implanted electrical devices, claustrophobia, seizure disorder)
  • Positive pregnancy test (for females)

研究组 & 干预措施

Active tDCS (with Speech-Language Treatment)

Active Comparator

tDCS Stimulation Dose: 1.5 mA for 20-mins

干预措施: Active Transcranial Direct Current Stimulation with SLT (Device)

Sham tDCS (with Speech-Language Treatment)

Sham Comparator

No tDCS stimulation

干预措施: Sham Transcranial Direct Current Stimulation with SLT (Device)

结局指标

主要结局

Change in correct naming of nouns on Philadelphia Naming Test.

时间窗: Immediately after 1st and 2nd treatment phases and at 10 follow up after study completion

Naming gains for untreated items.

次要结局

  • Change in correct naming of verbs on Action Naming Test(Immediately after 1st and 2nd treatment phases and at 10 follow up after study completion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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